Establishment and evaluation of a structured, multidisciplinary, guideline-based transition and (long-term) aftercare for children and adolescents formerly affected by cancer

Not Applicable

Recruiting

• Conditions: Cancer of any kind; C00-C97; Malignant neoplasms

• Registration Number: DRKS00029269
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Lübeck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Qualitative interviews prior to the start of the intervention:
- Written informed consent for the study
- In follow-up (patients)/active (staff).

Online interview:
- Age: minimum 18, maximum 39 years
- At least 5 years after end of treatment
- Identification via ICD-10 codes / OPS codes / ATC codes / EBM-GOPs.

RCT:
- Children and adolescents under 21 and one parent
- Regular oncology follow-up completed prior to intervention initiation

Qualitative interviews for intervention evaluation:
- Written informed consent for the study
- In follow-up as part of the RCT (patients)/working (staff)

Exclusion Criteria

Qualitative interviews prior to the start of the intervention:
- Insufficient knowledge of German
- Unknown time of therapy completion (patients)
- No written informed consent for the study

Online survey:
- Age: <18 years, >39 years
- End of treatment less than 5 years ago
- No malignant tumor disease

RCT:
- Individuals 21 years of age or older
- Patients in current oncological treatment
- Relocation within the intervention period expected
- No written informed consent for the study

Qualitative interviews for intervention evaluation:
- Insufficient knowledge of German
- No written informed consent for the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RCT:<br>- Self-efficacy of parents of affected children and adolescents after intervention, using a questionnaire (General self-efficacy expectancy scale according to Jerusalem and Schwarzer, 1999) at baseline, after the intervention, and 3 months after the intervention.